EUCTR2013-005054-30-IT进行中（未招募）不适用
A mechanistic study to evaluate the effect of Serelaxin on left ventricular function and its correlation with outcome in acute heart failure
Ospedale San Raffaele s.r.l.0 个研究点开始时间: 2014年3月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Dyspnea at rest or with minimal exertion
- •Pulmonary congestion on chest radiograph
- •Able to start serelaxin infusion within 16 hours from presentation to the hospital
- •Received IV furosemide of at least 40 mg (or equivalent) at any time between admission to emergency services (either ambulance or hospital, including the ED) and the start of screening for the study.
- •Impaired renal function defined as an estimated glomerular filtration rate (eGFR) on admission between 30-75 mL/min/1•73 m2, calculated using the simplified Modification of Diet in Renal Disease (sMDRD) equation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •Dyspnoea primarily due to non-cardiac causes
- •Women of child bearing potential or pregnant or nursing (lactating) women
- •Temperature >38.5°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment
- •Current (within 2 hours prior to screening) or planned treatment with any IV vasoactive therapies, including vasodilators, positive inotropic agents and vasopressors, or mechanical support, with the exception of IV furosemide (or equivalent) or IV nitrates = 0.1mg/kg if the patient has a systolic BP >150 mmHg at screening
- •Significant left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm2 or mean gradient >50 mmHg on prior or current echocardiogram) and severe mitral stenosis
- •Known hepatic impairment, or AST or ALT >3 times Upper Limit of Normal of unknown source
- •Known presence of active or recurrent bacterial, fungal or viral infection at the time of enrollment, e.g. evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infections (based on history and/or clinical findings, including laboratory results obtained during screening period, known significant pulmonary disease.
- •Shock regardless of aetiology
- •AHF caused by significant arrhythmias, acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy
- •Clinical evidence of Acute Coronary Syndrome currently or diagnosed within 30 days prior to enrolment. (Note that the diagnosis of acute coronary syndrome is a clinical diagnosis and that the sole presence of elevated troponin concentrations is not sufficient for a diagnosis of acute coronary syndrome, given that troponin concentrations may be significantly increased in the setting of AHF)
- •Troponin =3 times the level indicative of myocardial infarction
- •Known hypersensitivity to Serelaxin or similar substances or to any of the excipients
- •Pacemaker or ICD.
- •Implanted ferromagnetic cerebrovascular clips.
- •Claustrophobia.
- •Involved in other research studies
研究者
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